(88 days)
The Syringe Flushing/Cleaning Pump is intended to clean the Biosearch Endoscopic Instruments. The Syringe Flushing/Cleaning Pump is a device that helps remove debris that may get trapped inside the Biosearch Endoscopic Instrument.
The Disposable Syringe Flushing/Cleaning Pump for Biosearch Endoscopic Instruments, is a similar design to an existing legally marketed device. It is composed of a variety of medical grade plastics. The threaded connector is especially designed to fit the flushing port of the Biosearch Endoscopic device which impedes water leakage during the cleaning process. The dual check valve is an important feature because it provides an efficient transfer of the water, and/or cleaning fluid. This will provide a sanitary environment for the medical health professional to perform the extensive cleaning of the Biosearch Endoscopic Instruments.
The provided document is a 510(k) premarket notification for a medical device (Biosearch Syringe Flushing/Cleaning Pump for Biosearch Endoscopic Instruments). This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for reporting on a study that establishes acceptance criteria for a new device's performance against clinical endpoints.
Instead, the document focuses on safety and effectiveness primarily through demonstrating:
- Substantial Equivalence: By comparing the device's features and intended use to an existing legally marketed device (MILL-ROSE "Cleaning Adapter" {K922204}).
- Biocompatibility: By detailing tests performed on the materials used in the device.
Therefore, the requested information about acceptance criteria, device performance from a study, sample sizes, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for clinical efficacy or diagnostic accuracy is not applicable to this document. The device is a cleaning pump, not a diagnostic or therapeutic clinical device that would require such studies for its clearance.
However, I can extract information related to the material safety (biocompatibility) tests which serve as acceptance criteria for the various materials used in the device.
Acceptance Criteria and Study for Material Safety (Biocompatibility)
The "studies" described here are biocompatibility tests for the materials used in the device. The acceptance criterion is generally compliance with USP Class VI requirements or specific extractable/cytotoxicity test results.
1. Table of Acceptance Criteria and Reported Device Performance (Material Biocompatibility)
| Material | Test Performed | Acceptance Criteria | Reported Result (Performance) |
|---|---|---|---|
| PolyVinyl Chloride | USP tests for Systemic Injection Test, Intracutaneous Injection Test, Implantation test | Meets the requirements of USP Class VI Plastic | Meets the requirements of USP Class VI Plastic |
| Polyurethane Tecothane™ TT-1080A | MEM Elution Test | Meets the requirements of the Elution Test, USP XXII for the Elution Test | Meets the requirements of the Elution Test, USP XXII for the Elution Test |
| Polyurethane Tecothane™ TT-1080A | Biological Test for Plastics Class VI | Meets the requirements of the USP XXII for the Biological Test of Plastic | Meets the requirements of the USP XXII for the Biological Test of Plastic |
| Polyurethane Pellethane2363 Series | Acute Systemic Toxicity, Intracutaneous Toxicity, Implantation Test | Meets the requirements of the USP Class XI | Meets the requirements of the USP Class XI |
| Polycarbonate HPS2-1125 | Cytotoxicity, Hemolysis, Implantation, USP Class V Extractables, USP Physicochemical-Plastics | Meets the requirements of Class VI in Vivo & in Vitro Biological Reactivity, USP Physicochemical-Plastic | Meets the requirements of Class VI in Vivo & in Vitro Biological Reactivity, USP Physicochemical-Plastic |
| Dow Corning RX50 CT Silastic Ribbon | Cytotoxicity, Hemolysis, Implantation, USP Class V Extractables, USP Physicochemical-Plastics | Meets the requirements of Class VI in Vivo & in Vitro Biological Reactivity, USP Physicochemical-Plastic | Meets the requirements of Class VI in Vivo & in Vitro Biological Reactivity, USP Physicochemical-Plastic |
| Alpha PVC 2212/7 118 RSI Clear | USPXX Systemic Injection Test, USPXX Intramuscular implantation, USP XX Intracutaneous Test, Direct Exposure Cytotoxicity Test | Meets the USP Class VI requirements | Meets the USP Class VI requirements |
| Cyrolite® G20-300-001 | Systemic Toxicity, Intracutaneous Toxicity, MEM Elution, Hemolysis, Pyrogen, Guinea Pig Max. Implantation Test | Meets the USP Class VI requirements | Meets the USP Class VI requirements |
| Cyrolite® G20-100-001 | Systemic Toxicity, Intracutaneous Toxicity, Implantation Test Hemolysis, MEM Elution Pyrogen, Guinea Pig Max. | Meets the USP Class VI requirements | Meets the USP Class VI requirements |
| Radel R-5100 | Systemic Toxicity, Intracutaneous Toxicity, Implantation Test | Meets the USP Class VI requirements | Meets the USP Class VI requirements |
| Silastic Medical Grade {7-4735, 7-4750, 7-4765} | Hemolysis, Intracutaneous Injection, Systemic Injection Intramuscular Implant | Meets the USP Class VI Plastic Tests | Meets the USP Class VI Plastic Tests |
| Silastic Biomedical Grade Liquid {Q-7-480, 6860} | Hemolysis, Skin Sensitization USP Class V Extractables | Passes the Hemolysis Skin Sensitization, & USP Class V Extractables Tests | Passes the Hemolysis Skin Sensitization, & USP Class V Extractables Tests |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated in terms of number of test subjects or samples per test for each material. Biocompatibility tests usually involve a statistical number of in vitro or in vivo samples (e.g., cell cultures, animal models) as defined by the specific USP or ISO standards for each test. This document only reports the results against the standard.
- Data Provenance: "Vendor Supplied" for many materials, indicating the data was provided by the raw material manufacturers. Some tests have specific dates (e.g., 6/26/91-6/28/91), suggesting they were conducted at specific times, likely by the material vendors or contract labs. The country of origin for the data is not specified, but the applicant company is US-based. These are typically retrospective reports on material properties.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. For biocompatibility tests, the "ground truth" is defined by the established scientific protocols and criteria within the USP (United States Pharmacopeia) guidelines or similar international standards (e.g., ISO 10993). The interpretation is typically performed by specialists in toxicology or microbiology, rather than expert consensus as in a clinical diagnostic study. No specific number or qualifications of "experts" are provided in this document as would be for clinical endpoint studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements in human interpretations of clinical data. This is not relevant for standardized laboratory biocompatibility tests, where results are objectively measured against defined pass/fail criteria.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This device is a manual cleaning pump, not an AI-assisted diagnostic or therapeutic tool. No MRMC study was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" equivalent for these material tests is compliance with established biological safety standards and test parameters (e.g., USP Class VI requirements, specific elution limits, absence of cytotoxicity). These standards are developed through extensive scientific research and consensus in the field of biocompatibility.
8. The sample size for the training set
- Not Applicable. This is not a machine learning or AI-driven device, so there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. (No training set).
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.